TOTAL SHOULDER PROSTHESIS

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

ENCORE ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Total Shoulder Prosthesis.

Pre-market Notification Details

Device IDK950651
510k NumberK950651
Device Name:TOTAL SHOULDER PROSTHESIS
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Applicant ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin,  TX  78759
ContactJ. D Webb
CorrespondentJ. D Webb
ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin,  TX  78759
Product CodeKWS  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-13
Decision Date1995-05-30

NIH GUDID Devices

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